Data / Medical devices / United States / Sail Fusion
Sail Fusion: FDA-registered device maker in Del Mar, CA, United States, 1 510(k) clearance
Sail Fusion is registered with the FDA (registration 3031024716) in Del Mar, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 20, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3031024716
- Address
- 2010 Jimmy Durante Blvd Ste 200, Del Mar, CA, United States, 92014
- Owner or operator
- SAIL Fusion (10090703)
- Roles
- Complaint file establishment
- First device listed
- April 30, 2024
- Registered through
- 2026
- Brand names listed
- BowTie SI Joint Fusion System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Complaint file establishment | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 20, 2024 | K232149 | BowTie SI Joint Fusion System | OUR | Substantially Equivalent | Sail Fusion, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Surgical, Instrument
- All makers of Sacroiliac Joint Fixation
- All makers of Orthopedic Manual Surgical Instrument
Updated April 20, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.